A study to assess the safety and efficacy of full dose of Sofosbuvir and Daclatasvir in ESRD patients on Haemodialysis at GMC Anantnag
Keywords:
Sofosbuvir, Daclatasvir, ESRD, Haemodialysis, Hepatitis C, Safety,Efficacy.Abstract
Background: Hepatitis C virus (HCV) infection remains a significant challenge in patients with end-stage renal disease (ESRD) undergoing haemodialysis, leading to increased morbidity, mortality, and risk of nosocomial transmission. The introduction of direct-acting antivirals (DAAs) such as Sofosbuvir and Daclatasvir (SOF-DCV) has transformed HCV therapy, but data regarding their safety and efficacy in the ESRD population remain limited.
Objective: To evaluate the safety, tolerability, and efficacy of full-dose Sofosbuvir (400 mg) and Daclatasvir (60 mg) combination therapy in ESRD patients on maintenance haemodialysis.
Methods: A cross-sectional study was conducted on 250 HCV-infected ESRD patients undergoing haemodialysis at Government Medical College, Anantnag. Patients received full-dose SOF-DCV daily for 12 weeks, with extension to 24 weeks for decompensated cirrhotics. Biochemical, hematological, and renal parameters were assessed pre- and post-treatment. Statistical analysis was performed using paired t-tests and Wilcoxon signed-rank tests with significance set at p < 0.05
Results: The majority of patients were male (66.4%) and aged 20–39 years (56.4%). Post-treatment, significant reductions were observed in ALT (↓13.9 U/L, p<0.001), AST (↓16.0 U/L, p<0.001), and total bilirubin (↓0.11 mg/dL, p=0.012), with a significant rise in serum albumin (↑0.26 g/dL, p=0.003) and hemoglobin (↑0.17 g/dL, p=0.046). Renal indices (creatinine, urea, eGFR) remained unchanged (p>0.05), indicating no nephrotoxicity. No serious adverse effects were reported during or after therapy.
Conclusion: Full-dose Sofosbuvir and Daclatasvir therapy is both safe and highly effective in ESRD patients on maintenance haemodialysis. The regimen achieves marked hepatic improvement without renal toxicity, supporting its use as a standard, cost-effective antiviral option in this high-risk group, particularly in resource-limited settings.
